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Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis

Study acronym: REALPASS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2027 → Jun 2028
Enrollment reduced 53% 75 → 35 participants
See other at-risk trials from Cordis US Corp.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 75 → 35 participants Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Dec 2025 to Jun 23, 2026
    • Primary endpoints: details revised at 1 of 3 entries
    • Primary and study completion pushed from Dec 2027 to Jun 2028
    • Trial sites expanded: 0 → 8 locations
    • Eligibility criteria expanded, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.
Trial Details
NCT Number NCT07122518
Lead Sponsor Cordis US Corp.
Collaborators: Congenital Cardiovascular Interventional Study Consortium (CCISC)
Conditions
(from sponsor)		 Pulmonary Artery Stenosis
Related terms Stenosis, Pulmonary Artery
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov